高效液相色谱法测定头孢泊肟酯含量的方法学研究

Study on Assay of Cefpodoxime Proxetil by Modified HPLC

目的 对头孢泊肟酯及其制剂含量的高效液相色谱检测法进行改进,并与紫外分光光度法作比较.方法 以ODS- C18为固定相,甲醇-水（50∶50）为流动相,流速为1.5 mL·min^-1,柱温为40 ℃,检测波长235 nm.结果 头孢泊肟酯的浓度在25～150 μg·mL^-1内线性关系良好,回归方程为：A=7.457C^-1.1287,r=0.999 9（n=7）,测定头孢泊肟酯胶囊含量重复性良好,RSD为1%（n=9）.头孢泊肟酯胶囊的平均回收率为98.56%,平均含量为101.54%.结论 本法简便、快速、准确、灵敏,可用于头孢泊肟酯及其制剂的含量测定.

OBJECTIVE To develop an modified HPLC method for the determination of cefpodoxime proxetil or cefpodoxime proxetil capsules suspension, comparing with UV-determination, METHODS Column： ODS-C18 ; mobile phase ： methanol： water （ 50 ： 50）, flow rate：1. 5 mL · min^-1, column temperature ：40℃, detection wavelength： 235 nm, RESULTS The standard curve was rectilinear within the range of 25 - 150 μg · mL^-1 cefpodoxime proxetil and r = 0.999 9 （ n = 7）. The precision of cefpodoxime proxetil capsule was good and the RSD was 1% （n = 9）. The average recovery rate of capsule was 98.56%, the average content was 101, 54%. CONCLUSION The method is simple, rapid, accurate and sensitive for dete-rmination of cefpodoxime proxetil or cefpodoxime proxetil capsules suspension.